The FDA has granted 510(k) regulatory clearance to Ambu's aScope, a single-use gastroscope, and aBox 2, a display unit, the company said Feb. 4.
The aScope Gastro is Ambu's first sterile single-use gastroscope and includes imaging and design features. With its launch, Ambu enters the gastroscopy market, according to a news release from Ambu.
Ambu also said it plans to introduce a single-use duodenoscope, a colonoscope and a cholangioscope.